EUCTR2011-005806-32-DE
Active, not recruiting
Not Applicable
Clinical Study to Collect Clinical Data Sets for Development of Insulin Glargine Titration Algorithms - Delta Study
ikfe GmbH0 sitesJanuary 3, 2012
ConditionsType 2 diabetes mellitus receiving BOT Therapy or insulin therapy onlyMedDRA version: 14.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
DrugsLantus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 diabetes mellitus receiving BOT Therapy or insulin therapy only
- Sponsor
- ikfe GmbH
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Type 2 diabetes mellitus
- •2\.Improvement of an existing BOT with Insulin Glargine \+ OAD or Insulin Glargine alone
- •3\.HbA1c between 6\.5% and 9\.5% inclusively
- •4\.Age between 30 and 75 years inclusively
- •5\.Body mass index \=40 kg/m2
- •6\.Patient consents that his/her family physician will be informed of trial participation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 50
Exclusion Criteria
- •1\.Type 1 diabetes mellitus
- •2\.Instable OAD therapy during the last 6 weeks prior to the study
- •3\.Severe retinopathy, hepatic or renal dysfunction or clinically relevant other major diseases
- •4\.Lack of compliance or other justifications that, in the discretion of the investigator, precludes satisfactory participation in the study
- •5\.Subject without legal capacity
- •6\.Pregnant or lactating women
- •7\.History of drug or alcohol abuse within the last five years prior to screening
- •8\.Anamnestic history of hypersensitivity to the study drugs (or any component of the study drug) or to drugs with similar chemical structures
- •9\.History of severe or multiple allergies
- •10\.Treatment with any other investigational drug within 3 months prior to screening
Outcomes
Primary Outcomes
Not specified
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